Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
- Conditions
- Overweight
- Registration Number
- NCT03223987
- Lead Sponsor
- Bio-Strath AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Women, 25 to 35 years, BMI 30-35<br><br> - German speaking<br><br> - Smartphone owner<br><br>Exclusion Criteria:<br><br> - Contraindications to the class of drugs under study, e.g. known hypersensitivity or<br> allergy to class of drugs or the investigational product,<br><br> - Women who are pregnant or breast feeding,<br><br> - Intention to become pregnant during the course of the study,<br><br> - Lack of safe contraception, defined as: Female participants of childbearing<br> potential, not using and not willing to continue using a medically reliable method<br> of contraception for the entire study duration, such as oral, injectable, or<br> implantable contraceptives, or intrauterine contraceptive devices, or who are not<br> using any other method considered sufficiently reliable by the investigator in<br> individual cases.<br><br> - Please note that female participants who are surgically sterilised / hysterectomised<br> or post-menopausal for longer than 2 years are not considered as being of child<br> bearing potential.<br><br> - Other clinically significant concomitant disease states (e.g., renal failure,<br> hepatic dysfunction, cardiovascular disease, etc.),<br><br> - Known or suspected non-compliance, drug or alcohol abuse,<br><br> - Inability to follow the procedures of the study, e.g. due to language problems,<br> psychological disorders, dementia, etc. of the participant,<br><br> - Participation in another study with investigational drug within the 30 days<br> preceding and during the present study,<br><br> - Enrolment of the investigator, his/her family members, employees and other dependent<br> persons<br><br> - any kind of nutritional intervention due to a disease in the past 6 months<br><br> - any mean of weight reduction in the past 6 months<br><br> - Severe health problems in the last 6 months<br><br> - Chronic digestive system problems<br><br> - Medication against constipation and diarrhea<br><br> - Mental problems<br><br> - Major surgery<br><br> - Allergies or Atopy<br><br> - Drug intolerance<br><br> - Antibiotics within 12 months before study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantitative difference in microbiome composition.
- Secondary Outcome Measures
Name Time Method BMI